3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages

The primary objective of this study is to assess the safety of the 3D Transcranial Ultrasound Brain Imaging (3D TRUBI) device in Traumatic Brain Injury (TBI) patients with intracranial hemorrhage (ICH). The secondary objective is to assess the diagnostic potential of 3D TRUBI. The latter will be achieved by comparison of 3D TRUBI scans with admission head computed tomography (CT), the standard of care diagnostic modality. Demonstrating the feasibility and safety of the 3D TRUBI system is the first step toward expanding access of an alternative to CT for diagnostic imaging and triage of mass casualties of war or natural disasters in the field and in rapidly deployed medical centers or other austere environments.

NCT Number	NCT06780436
Lead Sponsor	The Geneva Foundation Collaborators: Brooke Army Medical Center, Uniformed Services University of the Health Sciences
Conditions	Traumatic Brain Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhages, Ultrasound Exams, 3D SONOGRAPHY
Enrollment	20 participants
Start Date	2024-12-04
Primary Completion	2026-08 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-03-20